Needle assembly

ABSTRACT

There is disclosed a needle assembly comprising a needle, a needle-retaining portion, a removable needle protector portion, and a resilient member for removing liquid from the surface of the needle which is disposed around the needle rearward of its point. The liquid removing member has a needle-accommodating opening with a diameter approximately that of the outside diameter of the needle. The member is contained within the needle protector portion and removable from the needle with the removal of the needle protector portion from the assembly. Also disclosed are blood bag systems comprising a donor bag and the aforementioned needle assembly.

CROSS=REFERENCE TO RELATED APPLICATION

This is a continuation-in-part of co-pending application U.S. Ser. No.386,549, filed June 9, 1982, now U.S. Pat. No. 4,435,177 issued Mar. 6,1984.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to and has among its objects the provision ofnovel needle assemblies. It is a particular object of the presentinvention to provide a needle assembly for use in the collection ofblood from a donor. Further objects of the invention will be evidentfrom the following description wherein parts and percentages are byweight unless otherwise specified.

2. Description of the Prior Art

In conventional blood banking practice, blood is collectedd from a donorinto a sterile, flexible, plastic container (donor bag), which isusually part of a blood bag system to be used in the processing of thecollected blood into components. The donor bag generally contains ananticoagulant which mixes with the collected blood. Attached to thedonor bag by means of flexible tubing is a needle for making avenipuncture in the donor's arm. It is, or course, mandatory to maintainthe sterile integrity of the needle used for the venipuncture. If theneedle is contaminated it could be dangerous to the blood donor, and thecontamination could be washed into the collected blood. The needleshould operate with minimal discomfort to the donor.

Conventional donor needles usually comprise a needle normally with asharpened forward end for the venipuncture, a needle-retaining means,and a needle protector. Customarily, blood bag systems are sterilizedafter assembly. During the sterilization procedure droplets ofanticoagulant may enter the needle and pass into the needle protector.This anticoagulant liquid adheres to the needle surface and duringvenipuncture may cause an unpleasant stinging sensation in a donor or atleast cause apprehension in the mind of a donor. Removal of the liquidby wiping the needle surface after the needle protector is removed isdifficult because sterility must be maintained.

Some workers have approached the above problem by designing a needleprotector with a front portion with an inside diameter approximately thesame diameter as the needle's outside diameter, therefore fittingtightly around the needle (U.S. Pat. No. 3,523,530). In this wayanticoagulant solution in a donor bag is kept from leaking out of theneedle and filling the protector. However, such an approach is less thansatisfactory for removing residual liquid on the full surface of theneedle. Such liquid may get in the needle protector during sterilizationof the blood bag assembly. Steam sterilization is generally employed andcauses the anticoagulant in the donor bag to vaporize, a situation whichis actually necessary for the sterilization of the needle.

It is also known to imbed the needle in a rubber or cork stopper (U.S.Pat. Nos. 2,688,963; 2,667,163; 2,688,964; 3,416,657). However, thisapproach is disadvantageous not only because of the deleterious impacton sterilization but also because the needle point may become eitherdamaged or coated with particles or both.

Other needle assemblies for parenteral use are known in the art. Forexample, donor needles for blood donor assemblies are described in U.S.Pat. Nos. 2,689,562 and 4,091,811. U.S. Pat. Nos. 2,938,238; 3,406,687;and 3,523,531; disclose needle assemblies for parenteral administration;and syringes are disclosed in U.S. Pat. Nos. 2,708,438; 1,494,973; and3,416,657.

SUMMARY OF THE INVENTION

The invention described herein is a needle assembly comprising a needle,a needle-retaining portion, a needle protector portion, and a resilientmember positioned around a portion of, and disposed rearward of thepoint of, said needle in a fashion to remove liquid from the surface ofthe needle. The liquid removing member has a needle-accommodatingopening with a diameter approximately that of the outside diameter ofthe needle. The liquid-removing member is contained within the needleprotector portion and is removable from the needle with the removal ofthe needle protector portion from the needle assembly.

Further, this invention provides a blood bag assembly comprising aflexible blood bag with flexible tubing and outlet ports attachedthereto. The needle assembly of the invention is attached to theflexible tubing and allows for venipuncture into the donor's arm. Theblood bag assembly may comprise only a donor or collection bag or it mayinclude a donor bag and one or more satellite bags for the collection ofblood and the processing of the collected blood into components.

The primary advantage of the invention is that the needle, with theneedle protector and liquid-removing member removed, is free of asubstantial portion of any liquid which otherwise might be present onthe needle surface. With respect to blood collection, discomfort to thedonor is minimized. Furthermore, the needle assembly of the inventionprovides for maximum maintenance of sterility of the needle surface.Thus, the danger of contamination of the donor or the collected blood isminimized.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of a needle assembly in accordance with theinvention.

FIG. 2 is a sectional view taken along line 2--2 of FIG. 1.

FIG. 3 is based on FIG. 2 but depicts an alternate embodiment of thepresent invention.

FIG. 4 is a front elevational view of a blood bag containing a needleassembly in accordance with the invention attached to the blood bag bymeans of flexible tubing.

FIG. 5 is a cross sectional view of FIG. 4 as shown at line 5--5.

FIG. 6 is a front elevational view of a blood bag including the needleassembly of the invention.

FIG. 7 is a top plan view of an alternate embodiment of the needleassembly.

FIG. 8 is a cross sectional view taken along line 8--8 of FIG. 7.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention will be described in detail with reference to the attacheddrawings. In the following description emphasis is directed to a bloodbag assembly with the instant needle assembly. This emphasis is by wayof example only and is not meant to limit the invention. The presentneedle assembly may be adapted to all kinds of parenteral use where thepresence of liquid on the surface of a needle is to be minimized.

The details of needle assembly 10 are best seen in FIGS. 1-3. As shownin these figures the needle assembly includes a needle 12 sharpened atits forward end 14. AT its rearward end the needle is permanentlyretained in a bore in needle-retaining means 16, which has indentations16a and 16b and thus may also serve as a handle or hub section to begrasped in the use of assembly 10. Preferably, means 16 has a slantedbottom surface 16c so that means 16 may fit closely to a donor's armwhen the needle assembly is in use. The needle is retained in 16 bymeans of an adhesive or the like or other suitable modes of retentionknown in the art. Retaining means 16 may be formed from a rigid ornon-rigid material such as a medically acceptable thermoplastic, forexample, polystyrene, polycarbonate, rigid polyvinylchloride, and thelike. Retaining means 16 has a narrowed, tube-receiving section 18 atits rear designed to fit inside flexible tubing such as that found on ablood bag. Thus, the needle's passage is directly connected throughsection 18 to the passage of such flexible tubing. The forward part ofmeans 16 is designed to receive needle protector 20, which surroundsneedle 12 and protects the needle's sterility. Protector 20 is bonded toretaining means 16 by means of an adhesive or other suitable bondingmaterial. Generally, needle protector 20 is formed of a rigid ornon-rigid plastic such as that used for needle-retaining means 16. Onceassembled, the combination of needle protector 20 and retaining means 16acts as a one-piece unit. Other modes of forming a needle and protectorcombination will be evident to those skilled in the art and arecontemplated in the present invention.

Surrounding needle 12 at its rearward end at a point near the handle orhub section is flexible resilient member 22 made of rubber, medicalgrade elastomer, or the like. Member 22 has a needle-accommodatingopening having a diameter approximately that of the outside diameter ofneedle 12, thus providing a positioning of the needle-contacting portionof member 22 about needle 12 and exerting a certain inward pressure onneedle 12 such that liquid on the surface of the needle will be removedas member 22 is disengaged from needle 12. Thus, the diameter of theopening should be such as to provide a gentle, liquid-removing wipingaction on the needle surface without causing damage to the needlesurface including any lubricant on the needle surface such as a siliconecoating. Preferably, the opening of 22 should be slightly smaller, about4-10%, than the outside diameter of the needle. In another preferredarrangement the diameter of the opening is such that the lubricatingcoating on the needle surface is distributed evenly by the action ofmember 22, thus providing a significant reduction, usually about 25% ormore, in the shaft drag of the needle upon its insertion into the arm ofa donor. Member 22 may take the form of a rubber ring or a rubber septum(22a in FIG. 3).

As can be seen from FIGS. 1 and 2 the rearward portion 20a of protector20 is flanged outwardly such that the inside diameter of the rearportion of 20 is larger than the inside diameter of the front portion of20. Member 22 is positioned entirely within the rearward portion ofprotector 20. Referring now to FIG. 3 the enlarged rear portion 20a ofprotector 20 has a plurality of inwardly protruding ribs 20b forretainment of 22 within 20a. As can be seen in FIG. 3, the outsidediameter of 22 is smaller than the inside diameter of 20 at portion 20a.This allows the portion of the assembly rearward of member 22 to besterilized during the steam sterilization procedure. As described above,during steam sterilization of the blood bag assembly, vaporizedanticoagulant solution enters the needle protector resulting insterilization. Member 22 must be designed to permit sterilization of theentire area inside the needle protector. Other designs of member 22 toachieve this result will be suggested to those skilled in the art fromthe teaching contained herein. For example, in FIG. 5 septum 22a issquare shaped, thus providing passage of vaporized anticoagulantsolution on both sides of 22a within protector 20. The outside diameterof member 22a at its four corners is slightly larger than the insidediameter of the rearward portion of 20 thus allowing a member 22a to beheld in protector 20 by means of friction. Member 22 may also have anelliptical shape for the above purpose.

Needle-retaining means 16 has a narrowed portion at a point immediatelyrearwardd of needle protector 20, with peripheral, frangible,circumferential groove 24 which provides for a thickness preferably ofabout 0.012±0.001 mm at its narrowest point. In general, groove 24 isdesigned to facilitate the removal of needle protector 20 and a portionof means 16 from needle assembly 10 by twisting to rupture groove 24.The needle assembly 10 additionally includes a raised portion 26, inretaining means 16, which may take the form of an arrowhead to show theorientation of bevel 28 of the sharpened end of the needle when it ishidden from view, e.g., by being placed in the arm of a donor. The pointof 26 may also be aligned during assembly with line marker 30 forward ofgroove 24. In this respect portion 26 in conjunction with line 30 actsto provide a tamper-evident feature to assembly 10. Thus, it may bereadily evident to the user, simply by tactily sensing the integrity ofgroove 24 and/or looking at the position of 26 and 30, whether theneedle assembly has been tampered with and sterility breached.

In the above there has been described a particular tamper-evidentfeature, which renders the needle assembly tamper-proof. It is of coursepossible to employ another tamper-evidencing feature in the needleassembly of the invention.

Protector 20 further comprises integral flanges 32 and 34 which providesuitable gripping means for rotating the protector to disengage thefront portion of the needle assembly from the rear portion along groove24.

Referring now to FIG. 4 there is shown flexible blood bag 36 having atits top end fitment 38 with donor (collection) tubing 40 and additionalports 42, 44, and 46, with tear-off caps 48, 50, and 52, respectively.However, any one of ports 42, 44, and 46 could be fitted with flexibletubing for internal connection to other blood bags in a blood bagsystem. Bag 36 has an opening 54 at its bottom end for suspending theblood bag upside down. Flexible donor tubing 40 with conventional clamp56 is integrally attached at one end to bag 36 and has needle assembly10 at its opposite end. The blood bag system as shown in FIG. 3 whenassembled may be sterilized as is customary in the art.

When blood is to be taken from a donor, retaining means 16 is grasped inone hand at its handle or hub portion. Flanges 32 and 34 on the needleprotector are grasped with the other hand and twisted so as to rupturegroove 24. The front portion of the needle assembly (needle protectorwith member 22 and a portion of the retaining means) is detached bypulling from the assembly thereby exposing the needle surface. Member 22slides over the needle surface and removes a substantial portion of anyliquid on the needle surface. The needle is then used in thevenipuncture operation to withdraw blood from a donor. When anappropriate amount of blood is drawn, clamp 56 can be closed to stop theflow of blood from the donor. Needle 12 may then be inserted back intomember 22 within the removed needle protector thus aiding in cleanlinessand safety.

The details of another embodiment of the needle assembly of theinvention are best seen in FIGS. 7 and 8. As shown in these figures theneedle assembly 60 includes a needle 62 sharpened at its forward end 64.At its rearward end the needle is permanently retained in a bore in aneedle-retaining means 66, which has indentations 66a and 66b and thusmay also serve as a handle or hub section to be grasped in the use ofassembly 60. Preferably, means 66 has a slanted bottom surface 66c sothat means 66 may fit closely to a donor's arm when the needle assemblyis in use. The needle is retained in 66 by means of an adhesive or thelike or other suitable modes of retention known in the art. Retainingmeans 66 is formed from a non-rigid material such as a medicallyacceptable elastomer or non-rigid thermoplastic, for example,polystyrene, polycarbonate, polyvinylchloride, and the like. Retainingmeans 66 has a narrow, tube-receiving section 68 at its rear designed tofit inside 66 in which it is retained by means of adhesive or the likeor other suitable modes of retention. Section 68 is designed also to fitinside flexible tubing such as that found on a blood bag. Thus, theneedle's passage is directly connected through section 68 to the passageof such flexible tubing. The forward part of means 66 is designed toreceive needle protector 70, which surrounds needle 62 and protects theneedle's sterility. Protector 70 is bonded to retaining means 66 bymeans of an adhesive or other suitable bonding material. Generally,needle protector 70 is formed of a rigid plastic or non-rigid plasticsuch as that used for needle-retaining means 66. Once assembled, thecombination of needle protector 70 and retaining means 66 acts as aone-piece unit.

Surrounding needle 62 at its rearward end at a point near the handle orhub section is flexible resilient portion 72 of retaining means 66 made,of course, of the same non-rigid material. Portion 72 of 66 has aneedle-accommodating opening having a diameter approximately that of theoutside diameter of needle 62, thus providing a positioning of theneedle-contacting portion of portion 72 about needle 62 and exerting acertain inward pressure on needle 62 such that liquid on the surface ofthe needle will be removed as portion 72 is disengaged from needle 62.Thus, as described above in FIGS. 1-5 the diameter of the opening shouldbe such as to provide a gentle, liquid-removing wiping action on theneedle surface without causing damage to the needle surface includingany lubricant on the needle surface such as a silicone coating.Preferably, the opening of 72 should be slightly smaller, about 4-10%,than the outside diameter of the needle. In another preferredarrangement the diameter of the opening is such that the lubricatingcoating on the needle surface is distributed evenly by the action ofmember 72, thus providing a significant reduction, usually about 25% ormore, in the shaft drag of the needle upon its insertion into the arm ofa donor.

Needle-retaining means 66 has a narrowed portion at a point immediatelyrearward of needle protector 70, with peripheral, frangile,circumferential groove 74 which provides for a thickness preferably ofabout 0.012±0.001 mm at its narrowest point. In general, groove 74 isdesigned to facilitate the removal of needle protector 70 and portion 72of means 66 from needle assembly 60 by twisting to rupture groove 74. Inthis way portion 72 acts in a manner previously described for member 22.

As can be seen from FIGS. 7 and 8 the rearward portion 70a of protector70 is flanged outwardly such that the inside diameter of the rearportion of 70 is larger than the inside diameter of the front portion of70. Portion 72 is positioned partly within the rearward portion ofprotector 70. Thus, portion 72 of 66 has a front part 72a having anoutside diameter about equal to the inside diameter of protector 70 intowhich 72a is secured as mentioned above. The bottom part 72b of 72 hasan outside diameter about equal to the outside diameter of 70a thusproducing ledge part 72c similar to that found in FIGS. 2 and 3.

Needle assembly 70 additionally includes an arrowhead 76, in retainingmeans 66 to show the orientation of bevel 78 of the sharpened end of theneedle when it is hidden from view, e.g., by being placed in the arm ofa donor. The point of 76 may also be aligned during assembly with linemarker 80 forward of groove 74. In this respect 76 in conjuction withline 80 acts to provide a tamper-evident feature to assembly 60. Thus,it may be readily evident to the user, simply by tactily sensing theintegrity of groove 74 and/or looking at the position of 76 and 80,whether the needle assembly has been tampered with and sterilitybreached.

In the above there has been described a particular tamper-evidentfeature, which renders the needle assembly tamper-proof. As with thepreviously described embodiments of this invention, it is of coursepossible to employ another tamper-evidencing feature in the needleassembly.

Protector 70 further comprises integral flanges 82 and 84 which providesuitable gripping means for rotating the protector to disengage thefront portion of the needle assembly from the rear portion along groove74.

It should be obvious that needle assembly 60 may be substituted forneedle assembly 10 in FIG. 6.

We claim:
 1. A needle assembly comprising a needle, a needle-retainingportion, a removable needle protector portion, and a resilient memberfor removing liquid from the surface of said needle, at least a portionof said liquid-removing member being contained within and removable withsaid needle protector portion and being positioned around a portion of,and disposed rearward of the point of, said needle, said liquid-removingmember further having a needle-accommodating opening with an innerdiameter approximately that of the outside diameter of the needle andouter cross sectional dimensions such that at least one of thedimensions is less than the internal cross sectional dimension of theprotector, thereby providing a passageway for facilitating steamsterilization rearward of the liquid-removing member.
 2. The assembly ofclaim 1 wherein the resilient member is a rubber septum.
 3. The assemblyof claim 1 wherein the resilient member is a rubber ring.
 4. Theassembly of claim 1 wherein the needle-retaining portion and the needleprotector portion are separable from each other along a frangible,circumferential groove.
 5. The assembly of claim 1 wherein the needleprotector further includes flanges to facilitate gripping of the needleprotector portion.
 6. The assembly of claim 1 wherein theneedle-retaining portion further includes opposed, laterally-indentedportions to facilitate gripping of the needle-retaining portion.
 7. Theassembly of claim 1 which further includes a tamper-evident indicator.8. The assembly of claim 1 wherein the needle-retaining portion furtherincludes a flexible-tube-receiving section.
 9. The assembly of claim 1wherein said resilient member is an integral part of saidneedle-retaining portion but separable therefrom and removable with saidneedle-protecting portion.
 10. A blood bag assembly comprising a donorbag and the needle assembly of claim 1 or claim
 9. 11. The blood bagassembly of claim 10 which further comprises at least one satellite bag.12. In a needle and needle protector combination including aneedle-retaining portion permanently secured to the needle and separablefrom a needle protector portion along a frangible circumferentialgroove, the improvement which comprises a resilient member for removingliquid from the surface of said needle, at least a portion of saidliquid-removing member being contained within said needle protectorportion and removable from the combination with said needle protectorportion and disposed rearward of the point of said needle, saidliquid-removing member further having a needle-accommodating openingwith an inner diameter such that a gentle, liquid-removing wiping actionis exerted on the needle surface without damage to the surface of theneedle and outer cross sectional dimensions such that at least one ofthe dimensions is less than the internal cross sectional dimension ofthe protector, thereby providing a passageway facilitating steamsterilization rearward of the liquid-removing member.
 13. Thecombination of claim 12 wherein said resilient member is an integralpart of said needle-retaining portion but separable therefrom andremovable with said needle-protecting portion.
 14. A blood bag assemblycomprising a donor bag and the needle and needle protector combinationof claim 12 or claim
 13. 15. The blood bag assembly of claim 14 whichfurther comprises at least one satellite bag.
 16. The needle and needleprotector combination of claim 12 wherein the needle-accommodatingopening has a diameter which further provides for evenly distributinglubricant on the surface of the needle.